Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2023 and Provides Corporate Update U pcoming Prescription Drug User Fee Act (PDUFA) goal date of

Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2023 and Provides Corporate Update

N.J., May 15, 2023 (GLOBE NEWSWIRE) - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical

company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in

retinal indications, today announced recent corporate highlights and financial results for its fiscal second quarter

ended March 31, 2023.

to make significant progress in our pre-launch activities as we approach our PDUFA goal date set for August 29, 2023, just three

short months away. These initiatives are focused on positioning Outlook Therapeutics as an upcoming leader in the anti-VEGF

space by meeting FDA requirements for an ophthalmic approval. The ONS-5010 Biologics License Application (BLA) was submitted and accepted

for filing by the FDA as a 351(a) stand-alone BLA. We believe ONS-5010, if approved, has the potential to be the standard of care in

the retinal anti-VEGF space and look forward to potentially bringing to market the first FDA-approved ophthalmic formulation of bevacizumab,"

commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics.

Anticipated Milestones

Planning Underway to Support Potential Approval of the First Ophthalmic Formulation of Bevacizumab for Use in Retinal Indications

GlobalData, the use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50%

of all wet AMD injections in the United States each year. This represents approximately 3.5 million injections of off-label,

repackaged bevacizumab each year in the United States alone. Globally, the nine major markets account for an estimated $13.1

billion market for anti-VEGF drugs to treat retina diseases.

physicians and payors rely heavily on bevacizumab as an important option for treating wet AMD, ONS-5010 has been developed to address

the potential potency and safety issues that have been reported to be associated with using off-label, repackaged bevacizumab from compounding

pharmacies, including:

2022, Outlook Therapeutics submitted a PHSA 351(a) BLA for ONS-5010 as a standalone biologic to potentially become the only

approved ophthalmic formulation of bevacizumab. ONS-5010, if approved, cannot qualify as a biosimilar because the PHSA requires a biosimilar

to have the same "conditions of use" (e.g., indications) as a reference product. AVASTIN, the currently marketed non-ophthalmic

formulation of bevacizumab, is not approved by FDA for the treatment of wet AMD or other retinal diseases.

TWO Phase 3 clinical trial, which compared ONS-5010 (dosed monthly) with LUCENTIS (using the PIER dosing regimen), ONS-5010 showed significantly

higher results in improving BCVA by 15 letters from baseline at 11 months (41.7% compared to 23.1% in LUCENTIS group, p = 0.0052).

Patients receiving ONS-5010 also demonstrated statistically significant mean change in BCVA of 11.2 letters compared to 5.8 letters in

the control arm (p = 0.0043). Additionally, the majority of ONS-5010 subjects maintained or gained BCVA during the study (defined as

change from baseline in BCVA 0), with at least 80% of ONS-5010 subjects maintaining BCVA each month. Safety evaluations revealed

similar safety profiles of ONS-5010 and the comparator LUCENTIS. In fact, only one serious ocular adverse event occurred in the ONS-5010

arm (increase in intraocular pressure) in 1100 injections.

ONS-5010 / LYTENAVA (bevacizumab-vikg) will be the first ophthalmic formulation of bevacizumab, not a biosimilar.

/ LYTENAVA (bevacizumab-vikg) Pre-Launch Preparations Proceeding as Planned

of potential FDA marketing approval in 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class

partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Bio-pharma Services

for the finished drug product.

Outlook Therapeutics is

actively building out its sales and commercial team, and in September, 2022 Outlook Therapeutics entered into a strategic partnership

with AmerisourceBergen in preparation for the anticipated commercial launch in the United States of ONS-5010. As Outlook

Therapeutics moves toward a potential launch in the United States, AmerisourceBergen's commercialization support will

expand to include additional services. Through the agreement with AmerisourceBergen, Outlook Therapeutics expects to significantly

increase market access and efficient distribution of ONS-5010, if approved by the FDA. Moreover, working with AmerisourceBergen will

help to provide Outlook Therapeutics with an accelerated pathway to deliver a high-quality customer experience to retina specialists.

To bring ONS-5010 to market in a way that benefits all stakeholders - patients, clinicians, and payors - Outlook Therapeutics has

also been in collaborative discussions with payors and the retina community.

Outlook Therapeutics also

submitted a Marketing Authorization Application (MAA) in Europe, which was validated for review in December 2022. The formal

review process of the MAA by the EMA's Committee for Medicinal Products for Human Use (CHMP) is underway with an estimated decision

date expected in early 2024. In addition to pursuing potential strategic partnering opportunities in the EU and other regions, such as

the current partnership with Syntone Biopharma JV in China, Outlook Therapeutics is also exploring an expanded relationship

with AmerisourceBergen to support the launch of ONS-5010 in international markets. AmerisourceBergen increased its global distribution

capabilities in 2021 with the acquisition of PharmaLex and Alliance Healthcare, leading wholesalers and specialized service

provider of healthcare products in Europe.

to the clinical development program evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the

FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for

a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO), NORSE FOUR, and two planned

registration clinical trials evaluating the drug candidate for the treatment of diabetic macular edema (DME), NORSE FIVE and NORSE SIX.

Highlights for the Fiscal Second Quarter Ended March 31, 2023

second quarter ended March 31, 2023, Outlook Therapeutics reported a net loss attributable to common stockholders of $6.7

million, or $0.03 per basic and diluted share, compared to a net loss attributable to common stockholders of $19.7 million,

or $0.09 per basic and diluted share, for the same period last year.

31, 2023, Outlook Therapeutics has cash and cash equivalents of $43.7 million, which is expected to be sufficient to fund

its operations through the anticipated approval of the BLA for ONS-5010 in the third calendar quarter of 2023, and potentially through

the fourth calendar quarter of 2023.

/ LYTENAVA (bevacizumab-vikg)

an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD

and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to

treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies, products

that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace the need to use unapproved

repackaged oncologic IV bevacizumab from compounding pharmacies for the treatment of wet AMD.

is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial

growth factor (VEGF) and neutralizes VEGF's biologic activity through a steric blocking of the binding of VEGF to its receptors

Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab-vikg

to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation,

vascular leakage, and new blood vessel formation in the retina.

Outlook Therapeutics is

a biopharmaceutical company working to develop and launch ONS-5010/ LYTENAVA (bevacizumab-vikg) as the first FDA-approved ophthalmic

formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. The FDA accepted Outlook Therapeutics'

BLA submission for ONS-5010 to treat wet AMD with a PDUFA goal date of August 29, 2023. The submission is supported by Outlook Therapeutics'

wet AMD clinical program, which consists of three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE. If ONS-5010 ophthalmic bevacizumab

is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of

bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, and other markets.

As part of the Company's multi-year commercial planning process, and in anticipation of potential FDA approval in August 2023, Outlook

Therapeutics and AmerisourceBergen have entered into a strategic commercialization agreement to expand the Company's reach

for connecting to retina specialists and their patients. AmerisourceBergen will provide third-party logistics (3PL) services and distribution,

as well as pharmacovigilance services and other services in the United States. For more information, please visit www.outlooktherapeutics.com.

release contains forward-looking statements. All statements other than statements of historical facts are "forward-looking statements,"

including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as "anticipate,"

"believe," "continue," "could," "estimate," "expect," "may,"

"might," "intend," "potential," "predict," "should," or "will,"

the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others,

statements about ONS-5010's potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, including benefits

therefrom to patients, payors and physicians, including potential approval and commercial launch of ONS-5010 and the timing thereof,

expectations about the sufficiency of our capital, upcoming anticipated milestones, expectations concerning decisions of regulatory bodies,

including the FDA and the EMA, and the timing thereof, our estimated market, expectations concerning our relationship with AmerisourceBergen

and the benefits and potential expansion thereof, plans for and the timing of potential future clinical trials, including the expected

completion of NORSE SEVEN and the expected commencement of NORSE FOUR, NORSE FIVE and NORSE SIX, potential strategic partners, plans